Effects of a Physical Exercise Program on Patients Affected With Fibromyalgia

July 22, 2019 updated by: Jordi Gol i Gurina Foundation
Physical activity has been used for a number of years in the treatment of fibromyalgia (FM). The main objective of this study is to compare the effects of physical activity on two groups of women diagnosed with fibromyalgia (FM) in terms of pain, quality of life and the impact of the condition on their daily lives. Methods: this was a randomized clinical trial to assess the effects of physical activity performed by subjects assigned to one of two groups on the scores of three questionnaires (the pain Visual Analogue Scale, the FIQ questionnaire and the SF-36 health questionnaire) administered before and after the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Igualada, Barcelona, Spain, 08700
        • Espai Civic Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Women

  • Ages of 40 and 75
  • Diagnosis fibromyalgia (code M79.7)
  • Anoia region

Exclusion Criteria:

  • Pregnant
  • Unable to participate in the physical activity program.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Experimental: physical activity group
Other: Physical activity

The intervention group: engaged in a therapeutic physical activity program involving low-intensity exercise, strength and balance work for 2 days a week over a 12-week period, with each session lasting 90 minutes. Both the intervention group and the control group separately completed the various baseline surveys which were part of the study. Once the intervention was over, they answered them again, also separately.

The classes were led by an experienced physiotherapist who followed the physical exercise guidelines established by the American College of Sports Medicine (ACSM), although the intensity of the exercises was adapted to the participants' tolerance levels

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The visual analogue scale (VAS)
Time Frame: two months
evaluate pain, with a score of 0 to 10
two months
The Spanish version of the SF-36 questionnaire
Time Frame: two months
used to assess their perceived state of health. It includes eight variables: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health
two months
the Fibromyalgia Impact Questionnaire (FIQ)
Time Frame: two months
measures physical functioning, ability to undertake work and general well-being, with a score from 0 to 80.
two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jordi Gol i Gurina Foundation

Collaborators

Institut Catala de Salut

Investigators

  • Study Chair: JACOBO MENDIOROZ PEÑA, MD, Institut Catala de Salut

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2017

Primary Completion (Actual)

August 30, 2017

Study Completion (Actual)

December 15, 2018

Study Registration Dates

First Submitted

July 19, 2019

First Submitted That Met QC Criteria

July 22, 2019

First Posted (Actual)

July 24, 2019

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 22, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7Z17/032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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